Principal Validation Specialist, Quality Control

Genentech • Holly Springs, NC

1d • Onsite

About The Position

This role is at Roche/Genentech's new $2B greenfield facility in Holly Springs, North Carolina, which is focused on high-volume, highly-efficient Drug Product manufacturing. The facility leverages advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes to produce high-quality CVRM (Cardiovascular, Renal, and Metabolism) medicines and next-generation metabolic medicines targeting global obesity and Type 2 diabetes, with a planned launch in 2029. The Principal Validation Specialist will lead the site-level establishment, routine support, and continuous improvement of a "Best-in-Class" digital laboratory. This involves owning the QC instrumentation validation lifecycle from laboratory start-up to high-throughput routine operations, managing QC system changes, and providing technical support for the QC technology ecosystem to ensure a seamless, paperless, and "Data Integrity by Design" environment. This is a fast-paced, entrepreneurial environment with a high level of accountability, offering a unique opportunity to launch a state-of-the-art facility from the ground up and shape the organizational culture.

Requirements

• Hold a Bachelor’s degree in Life Sciences (Chemistry, Biology, or Biochemistry), Computer Science/Information Technology or a related field.
• Minimum 8 years in a GMP data environment with a focus on QC digital systems.
• Proven experience in lifecycle management of QC Digital systems.
• Experienced in operating as SME in complex digital laboratory environments.
• Proven experience building and maintaining complex static data (Specifications, Methods, Sampling Plans) in a production environment.
• Performed Validation (IQ/OQ/PQ) of Quality Control Laboratory Instrumentation.
• Experience performing formal Data Integrity assessments on computerized systems.
• Deep understanding in ALCOA+, GAMP 5 and CFR 21 Part 11/Annex 11.
• Excellent attention to detail and strong analytical problem-solving skills.
• Experience presenting during regulatory, or internal inspections.
• Strong communication and collaboration skills to work effectively with cross-functional teams.
• Ability to work on site in a flexible open space work environment and QC laboratories requiring gowning (lab coat, eye protection, gloves).
• Ability to work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours).
• May be required to lift up to 25lbs.
• May have to work with hazardous materials and chemicals.

Nice To Haves

• Administration experience in QC Software Applications.
• Experience with the implementation of a Greenfield QC Laboratory.

Responsibilities

• Lead the site-level establishment, routine support, and continuous improvement of a "Best-in-Class" digital laboratory at the Holly Springs facility.
• Own the QC instrumentation validation lifecycle, firstly at laboratory start up leading to high throughput routine operations.
• Own QC system management, change control, and technical support for the Holly Springs QC technology ecosystem to ensure a seamless, paperless, and “Data Integrity by Design” environment.
• Be the QC System Owner and lifecycle management for test equipment and instrumentation.
• Author and review equipment/computer system lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Protocols, Reports Operational and Administration Procedures).
• Serve as the site-level custodian for the creation, maintenance, and synchronization of all QC Master Data across the QC digital ecosystem.
• Configure and maintain instrument-specific master data to ensure seamless result transfer from raw data acquisition to the final execution layer.
• Lead the integration of local laboratory instruments (HPLC, balance, pH meter, etc.) into global data management systems.
• Monitor the performance of the integrated digital thread to ensure high-throughput testing remains uninterrupted and implement identified opportunities for continuous improvement.
• Act as the on-site Subject Matter Expert (SME) to troubleshoot system glitches, interface errors, or instrument connectivity issues.
• Coordinate with Local and Global IT for system patches, server maintenance, and version upgrades, ensuring minimal impact on lab operations.
• Lead the site-level Change Control process for QC digital systems, ensuring that any modifications to methods or workflows are fully validated and documented.
• Own Quality System records relating to QC Equipment.
• Manage the ongoing training and upskilling of QC users for system updates and digital best practices.
• Act as the primary liaison between Holly Springs QC and Global IT/Automation teams.
• Serve as a site representative on network-wide system validation teams formed to discuss emerging issues through resolution, and improve/standardize qualification of platform equipment.
• Collaborate with Site Quality and Operations to ensure the digital QC landscape supports site-level operations.
• Conduct and maintain comprehensive Data Integrity Assessments (DIA).
• Establish robust audit trail review processes to ensure all QC data adheres to ALCOA+ principles.
• Serve as the technical lead during regulatory inspections and internal audits for all matters related to QC electronic data, system security, and data integrity.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided.
• Relocation benefits are available for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees